intention-to-treat
Also written as: ITT
An analysis principle that includes all randomized participants in their originally assigned treatment groups, regardless of adherence or completion.
Full Definition
Intention-to-treat analysis represents the gold standard for primary efficacy analysis in cardiovascular clinical trials, preserving the benefits of randomization by analyzing patients according to their assigned treatment regardless of actual treatment received. This approach maintains the balance of known and unknown confounders achieved through randomization and provides the most conservative estimate of treatment effect. ITT analysis typically includes all randomized patients with at least one post-baseline assessment, though modified ITT populations may exclude patients who never received study treatment. The principle reflects real-world clinical practice where patient adherence and treatment modifications are common.
Usage
Usage note: Hyphenate when used as compound modifier; abbreviate as ITT only after first use in text.
In Context
- "The primary efficacy analysis was performed on the intention-to-treat population (n=4,657)." — Statistical analysis plan
- "Both intention-to-treat and per-protocol analyses supported the primary findings." — Results summary